MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP PRIMARY STEM 7MM MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." product location unknown.

Event Description

During a reverse shoulder arthroplasty procedure, the surgeon had difficulty implanting the humeral stem.The surgeon indicated there may be an issue with the porous spray coating of the stem.The procedure was completed with another stem.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was not confirmed.Product was visually examined.There is no noticeable damage to the shaft or collar of the stem.There are marks on the face of the stem which indicate the attempted impaction of the stem by the surgeon.A dimensional analysis was conducted and found all applicable dimensions to be conforming.The device history records were reviewed and no discrepancies were identified.Review of the complaint history determined that no further action is required.The complaint could not be confirmed as the device analysis indicated that the device met specification.

• Brand Name: COMP PRIMARY STEM 7MM MINI
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5940553
• MDR Text Key: 54393397
• Report Number: 0001825034-2016-03580
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113627
• Device Lot Number: 948220
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention